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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K884856
Device Name APTT REAGENT
Applicant
PRECISION BIOLOGICALS, INC.
11A PETTIPAS DR.
DARTMOUTH,  CA NS B3B 1K1
Applicant Contact TONY BEBBINGTON
Correspondent
PRECISION BIOLOGICALS, INC.
11A PETTIPAS DR.
DARTMOUTH,  CA NS B3B 1K1
Correspondent Contact TONY BEBBINGTON
Regulation Number864.7925
Classification Product Code
GFO  
Date Received11/18/1988
Decision Date 01/30/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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